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Comparative bioequivalence study between a novel matrix transdermal delivery system of fentanyl and a commercially available reservoir formulation
Author(s) -
Marier JeanFrancois,
Lor Mary,
Morin Josée,
Roux Lionel,
Di Marco Marika,
Morelli Gaetano,
Sædder Eva Aggerholm
Publication year - 2007
Publication title -
british journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.216
H-Index - 146
eISSN - 1365-2125
pISSN - 0306-5251
DOI - 10.1111/j.1365-2125.2006.02758.x
Subject(s) - transdermal , fentanyl , bioequivalence , pharmacokinetics , crossover study , irritability , medicine , confidence interval , pharmacology , bioavailability , anesthesia , alternative medicine , menopause , pathology , placebo
Aim To determine the pharmacokinetics, safety and performance of a novel matrix formulation of fentanyl. Methods Transdermal fentanyl was administered as the novel matrix and the Durogesic ® reservoir formulations (24 subjects, 100 µg h −1 ) in a randomized, fully replicate, four‐way crossover study. Serum concentrations of fentanyl were assayed by LC/MS/MS. Pharmacokinetic parameters of fentanyl and performance (adherence and skin irritability) were evaluated. Results Test/reference ratio (90% confidence intervals) for AUC 0– t , AUC inf and C max were 105.5% (99.4, 112.0), 105.3% (99.3, 111.6) and 111.4% (100.4, 123.6), respectively. Adherence and skin irritability results of the two formulations were similar. Conclusion The two formulations are expected to result in similar efficacy for the management of severe pain.